Pre-metered dose magazine for breath-actuated dry powder inhaler

ABSTRACT

A pre-metered dose assembly for consistently supplying precise doses of medicament is provided for a breath-actuated dry powder inhaler. The assembly includes a cap defining a dry powder delivery passageway for providing air to a dry powder supply port of a swirl chamber of a breath-actuated dry powder inhaler, and a magazine including a plurality of reservoirs for holding pre-metered doses of dry powder. One of the magazine and the cap is movable with respect to the other of the magazine and the cap for sequentially positioning the reservoirs within the delivery passageway of the cap. A breath-induced low pressure at an outlet port of the swirl chamber of the inhaler causes an air flow through the dry powder delivery passageway of the assembly and into the dry powder supply port of the swirl chamber that entrains dry powder from the reservoir positioned in the passageway for inhalation by a patient using the inhaler. The present disclosure also provides a breath-actuated dry powder inhaler including the pre-metered dose assembly in combination with a de-agglomerator for breaking up aggregates and micronizing particles of dry powder prior to inhalation of the powder by a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to provisional U.S. patentapplication Ser. No. 60/213,667, filed Jun. 23, 2000 (entitled“Pre-Metered Dose Magazine for Breath-Actuated Dry Powder Inhaler”), andprovisional U.S. patent application Ser. No. 60/213,382, filed Jun. 23,2000 (entitled “De-Agglomerator for Breath-Actuated Dry PowderInhaler”). Each of these co-pending applications is assigned to theassignee of the present disclosure and incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to a breath-actuated dry powder inhaler foradministering dry powder medicament to a patient. More particularly, thepresent disclosure relates to a magazine having a plurality ofindividually separated, pre-metered doses for a breath-actuated drypowder inhaler and a method for providing pre-metered doses of drypowder medicament for inhalation by a patient.

BACKGROUND OF THE INVENTION

Metered dose medicament inhalers are well known for dispensingmedicament to the lungs of a patient. In most cases, the inhalersinclude a reservoir containing dry powder medicament in bulk form, andmeans for metering the medicament from the reservoir in discrete amountsfor inhalation by a patient.

For example, U.S. Pat. No. 5,503,144, which is assigned to the assigneeof the present disclosure and incorporated herein by reference, shows abreath-actuated dry-powder inhaler having a medicament reservoir. Thereservoir contains dry-powder medicament in bulk form, and the inhalerincludes a metering chamber for removal of the powdered medicament fromthe reservoir in discrete amounts. The inhaler also includes an airinlet for entraining the removed powdered medicament through amouthpiece upon patient inhalation.

While the reservoir and metering chamber of the inhaler shown by U.S.Pat. No. 5,503,144 properly function to dispense discrete amounts ofpowdered medicament to a patient, there is desired an inhaler havingpre-metered doses of powdered medicament. Providing the powderedmedicament in pre-metered doses will further ensure that the medicamentis consistently dispensed to a patient in precise doses.

In particular, a device and method are desired for providingindividually sealed, pre-metered doses of dry powder medicament forinhalation by a patient through a dry powder inhaler and, in particular,a breath-actuated, dry powder inhaler.

An improved breath-actuated, dry powder inhaler, which substantiallyde-agglomerates and micronizes pre-metered doses of medicament is alsodesired to ensure that particles of the medicament are small enough foradequate penetration of the medicament into a bronchial region of apatient's lungs during inhalation.

SUMMARY OF THE INVENTION

The present disclosure accordingly provides a pre-metered dose assemblyfor consistently supplying precise doses of medicament to abreath-actuated dry powder inhaler. The assembly includes a cap defininga dry powder delivery passageway for providing air to a dry powdersupply port of a swirl chamber of a breath-actuated dry powder inhaler,and a magazine including a plurality of reservoirs for holdingpre-metered doses of dry powder. One of the magazine and the cap ismovable with respect to the other of the magazine and the cap forsequentially positioning the reservoirs within the delivery passagewayof the cap. A breath-induced low pressure at an outlet port of the swirlchamber of the inhaler causes an air flow through the dry powderdelivery passageway of the assembly and into the dry powder supply portof the swirl chamber. The air flow entrains dry powder from thereservoir positioned in the passageway for inhalation by a patient usingthe inhaler.

The present disclosure also provides a breath-actuated dry powderinhaler including the pre-metered dose assembly in combination with ade-agglomerator for breaking up aggregates and micronizing particles ofdry powder prior to inhalation of the powder by a patient. Thede-agglomerator includes an inner wall defining a swirl chamberextending along an axis from a first end to a second end, a dry powdersupply port, one or more primary air flow inlet ports, and an outletport. The supply port is at the first end of the swirl chamber forproviding fluid communication between the dry powder delivery passagewayof the pre-metered dose assembly and the first end of the swirl chamber.The primary air flow inlet ports are in the inner wall of the swirlchamber adjacent to or near the first end of the swirl chamber andprovide fluid communication between a region exterior to thede-agglomerator and the swirl chamber. The outlet port provides fluidcommunication between the second end of the swirl chamber and a regionexterior to the de-agglomerator.

A breath-induced low pressure at the outlet port of the de-agglomeratorcauses air flows into the swirl chamber through the dry powder supplyport and the inlet port. The air flows collide with each other and withthe wall of the swirl chamber prior to exiting through the outlet port,such that any powder entrained in the air flows is broken down andmicronized. The de-agglomerator further includes vanes at the first endof the swirl chamber for creating additional collisions and impacts ofentrained powder.

Further features and advantages of the presently disclosed pre-metereddose magazine and method for providing pre-metered doses will becomemore readily apparent to those having ordinary skill in the art to whichthe present disclosure relates from the following detailed descriptionand attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art will more readilyunderstand how to construct a pre-metered dose magazine and abreath-actuated, dry powder inhaler in accordance with the presentdisclosure, a preferred embodiments are described in detail below withreference to the drawing figures wherein:

FIG. 1A is a top isometric view of a breath-actuated, dry powder inhalerincluding a pre-metered dose magazine according to the presentdisclosure;

FIG. 1B is a sectional view of the inhaler of FIG. 1A;

FIG. 2 is a top isometric view of the inhaler of FIG. 1A with a cap ofthe inhaler removed;

FIG. 3 is a top isometric view of the inhaler of FIG. 1A with the capand the pre-metered dose magazine removed to reveal a de-agglomerator ofthe inhaler including a cover and a base;

FIG. 4 is a top isometric view of the base of the inhaler of FIG. 1A;

FIG. 5 is an exploded, bottom isometric view of the inhaler of FIG. 1A;

FIG. 6 is an enlarged bottom plan view of a portion of the cap of theinhaler of FIG. 1A;

FIG. 7 is an exploded, top isometric view of the cap and the pre-metereddose magazine of the inhaler of FIG. 1A;

FIG. 7a is a top isometric view of an alternative pre-metered dosemagazine for use with the inhaler of FIG. 1A;

FIG. 8 is a sectional view of portions of the cap and the pre-metereddose magazine of the inhaler of FIG. 1A;

FIG. 9 is a sectional view of the inhaler of FIG. 1A illustratingoperation of the inhaler; and

FIG. 10 is an exploded, top isometric view of an additionalbreath-actuated, dry powder inhaler according to the present disclosure.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIGS. 1A, 1B, 5 and 9 show a preferred embodiment of a pre-metered doseassembly 10 in a dry powder inhaler and, in particular, abreath-actuated, dry powder inhaler 12, all in accordance with thepresent disclosure. The pre-metered dose assembly 10 consistentlyfurnishes precise doses of dry powder, e.g., a dry powder medicament ormedicament composition, for inhalation by a patient using the dry powderinhaler 12.

The inhaler 12 generally includes the assembly 10, a swirl chamber 114extending along axis A, a dry powder supply port 122 in a first end 118of the swirl chamber, and an outlet port 132 at a second end 120 of theswirl chamber. The assembly 10 includes a cap 14 defining a dry powderdelivery passageway 16 for providing air to the dry powder supply port112 of the swirl chamber 114, and a magazine 18 including a plurality ofreservoirs 20 for holding pre-metered doses of dry powder.

During operation, one of the magazine 18 and the cap 14 is movable withrespect to the other of the magazine and the cap for sequentiallypositioning the reservoirs 20 of the magazine 18 within the deliverypassageway 16 of the cap 14. Then, a breath-induced low pressure at theoutlet port 132 of the swirl chamber 114 of the inhaler 12 causes an airflow, as indicated by arrow 1 in FIG. 9, through the dry powder deliverypassageway 16 into the dry powder supply port 122 of the swirl chamber114. As shown best in FIGS. 5, 6 and 9, the passageway 16 of the cap 14includes a venturi 22 (or venturi-type restriction) that causes thevelocity of the breath-induced air flow to increase. The air pressure inthe venturi 22 decreases as a result of the increased velocity, and thedrop in pressure causes the pre-metered dose of dry powder to bedragged, or entrained into the air flow traveling to the swirl chamber114.

Preferably, the magazine 18 is movable with respect to the cap 14 forsequentially positioning the dry powder reservoirs 20 of the magazine 18within the delivery passageway 16 of the cap 14. However, it should beunderstood that the magazine 18 could be made stationary, and the cap 14made moveable with respect to the magazine 18 for sequentiallypositioning the passageway 16 over the reservoirs 20.

As shown in FIGS. 1A, 1B, 2, 5, 7 and 9, the magazine 18 is providedwith an annular shape such that rotation of the annular magazine 18sequentially positions the plurality of the dry powder reservoirs 20within the delivery passageway 16 of the cap 14. However, it should beunderstood that the magazine 18 could be provided in other, suitableshapes and the cap 14 suitably adapted. For example, the magazine 18could be provided with a straight elongated shape, such that movement ofthe magazine in the direction of elongation sequentially positions thereservoirs 20 within the delivery passageway 16 of the cap 14.

In particular, the annular magazine 18 includes inner and outercircumferential surfaces 24, 26, and flat top and bottom annularsurfaces 28, 30. The magazine 18 also includes a dial 32 radiallyextending outwardly from the outer circumferential surface 26 forallowing a patient to grip and rotate the magazine 18. The dry powderreservoirs 20 are provided in the top surface 28 of the magazine 18 andare uniformly sized and spaced with respect to one another, as shownbest in FIGS. 2 and 7.

As shown in FIGS. 1A, 1B, 5, 7 and 9, the cap 14 is circular andincludes a cylindrical side wall 34 received on the outercircumferential surface 26 of the magazine 18, and a flat, bottomannular surface 36 received over the annular top surface 28 of themagazine 18. The magazine 18 and the cap 14, therefore, are adapted forrotation of the magazine 18 within the cap 14. As shown best in FIGS. 5,6 and 9, the bottom surface 36 of the cap 14 defines the dry powderdelivery passageway 16, which extends radially inwardly from a first end38 at the side wall 34 of the cap 14, to a second end 40 at an innercircumference of the annular bottom surface 36 of the cap 14. The cap 14also includes a first hood 42 extending downward from the first end 38of the delivery passageway 16, and creating an air inlet port to thepassageway 16 between the cap 14 and the magazine 18. A second hood 44extends downward from the second end 40 of the delivery passageway 16,into the central void of the annular magazine 18.

The assembly 10 preferably includes a seal for sealing the doses of drypowder in the reservoirs 20 of the magazine 18 in an airtight mannerprior to the reservoirs 20 being positioned within the deliverypassageway 16 of the cap 14. As shown best in FIGS. 7 and 9, the sealcomprises a thin plastic film 46 secured to the annular top surface 28of the magazine 18 and covering the dry powder in the reservoirs 20 inan airtight manner. The cap 14 includes means for piercing the film 46above each of the reservoirs 20 prior to the reservoirs 20 beingpositioned within the delivery passageway 16 of the cap 14. As shownbest in FIGS. 5 and 6, the means for piercing comprises a small barb 48extending downward from the annular bottom surface 36 of the cap 14 infront of the venturi 22 of the delivery passageway 16 (assuming acounter-clockwise rotation of the magazine 18 with respect to the cap14).

It is intended that a manufacturer will fill the reservoirs 20 of themagazine 18 with properly metered individual doses of dry powdermedicament, or medicament composition including medicament and asuitable particulate carrier such as lactose. The filled reservoirs 20are then sealed in an airtight manner, with the film 46 for example, andthe magazine 18 and the cap 14 are provided as an assembly 10 topatients for use with a breath actuated, dry powder inhaler. Thepre-metered dose assembly 10 may be provided as part of a disposableinhaler. Alternatively, the dose assembly 10 may be removably insertableinto a non-disposable inhaler so that an empty assembly can be replacedby a full assembly.

Referring to FIG. 7A, a seal for sealing the doses of dry powder in thereservoirs 20 in an airtight manner can alternatively comprisecontinuous seals 47 surrounding each reservoir on the top surface 28 ofthe magazine 18. Each seal 47 is made from a soft resilient material,such as a synthetic rubber, and is raised slightly above the level ofthe top surface 28 of the magazine 18 so that the seal 47 is compressedbetween the bottom surface 30 of the cap 14 and the top surface 28 ofthe magazine 18. The compressed seals 47 retain the dry powder in thereservoirs 20 in an airtight manner prior to the reservoirs being movedinto the delivery passageway 16. Means for piercing are not required.Preferably, the seals 47 are formed with the magazine 18 in a two stepinjection molding process.

Preferably, the magazine 18 and the cap 14 are movable with respect toeach other through a plurality of discrete increments, wherein at eachincrement one of the plurality of the dry powder reservoirs 20 of themagazine 18 is positioned within the delivery passageway 16 of the cap14. In addition, the magazine 18 and the cap 14 are preferably movablein a single direction only with respect to each other, so that a usercan access the reservoirs in sequence, without being able to access oneof the reservoirs more than once. Furthermore, movement between themagazine 18 and the cap 14 is preferably prevented after all the drypowder reservoirs 20 of the magazine 18 have been positioned in thedelivery passageway 16 of the cover, to provide an indication to apatient that all of the doses of the magazine 18 have been used.

As shown best in FIGS. 7 and 8, one of the magazine 18 and the cap 14includes a plurality of teeth 50, and the other of the magazine 18 andthe cap 14 includes a resilient pawl 52 sequentially passing over theteeth during movement of the magazine 18 with respect to the cap 14.When the pawl 52 is between two of the teeth 50, a reservoir 20 of themagazine 18 corresponding to the two teeth is positioned in the deliverypassageway 16 of the cap 14. Each of the plurality of teeth 50 has asloped first side 54 allowing passage of the pawl 52 in only a firstdirection, and a straight second side 56 preventing passage of the pawlin a second direction. Accordingly, as shown, the magazine 18 can onlybe rotated in a counter-clockwise direction with respect to the cap 14.In addition, one tooth 58 has straight first and second sides 60, 62that prevent passage of the pawl 52 past the tooth 58 in any direction.The “last” tooth 58 is positioned to correspond with an empty portion 64of the top surface 28 of the magazine 18 to prevent movement between themagazine 18 and the cap 14 after all the reservoirs 20 of the magazine18 have been rotated through the delivery passageway 16.

The assembly 10 also includes a coupler for securing the cap 14 to themagazine 18. As shown best in FIGS. 5 and 9, the coupler comprisesresilient tangs 66 extending radially inward from a bottom edge of theside wall 34 of the cap 14 and engaging a circumferential groove 68 ofthe outer circumferential surface 26 of the magazine 18. The tangs 66and the groove 68 prevent the cap 14 from being lifted off the magazine18, yet allow the magazine 18 to rotate with respect to the cap 14.

The assembly 10 additionally includes an indicator for indicating thenumber of dry powder reservoirs 20 containing dry powder, i.e., thenumber of pre-metered doses remaining in the magazine 18. As shown inFIGS. 1, 5 and 7, the indicator comprises an annular transparent portion70 of the cap 14, which allows the reservoirs 20 of the magazine 18 tobe viewed through the cap 14 for a determination of how many of thereservoirs 20 contain medicament. Other suitable indicators couldalternatively be provided. For example, sequential printed numberscorresponding to the reservoirs 20 of the magazine 18 can be provided onthe dial 32 of the magazine 18, so that the number of reservoirs 20 thathave passed through the delivery passageway 16 of the cap 14 can bedetermined by reference to the printed numbers.

Referring to FIGS. 1A through 4 and FIG. 9, the inhaler preferablyincludes both the presently disclosed pre-metered dose assembly and ade-agglomerator 110. The de-agglomerator 110 is disclosed in co-pendingprovisional U.S. patent application Ser. No. 60/213,382, filed Jun. 23,2000 (entitled “De-Agglomerator for Breath-Actuated Dry PowderInhaler”). The co-pending application is assigned to the assignee of thepresent disclosure and has been incorporated herein by reference. As itsname implies, the de-agglomerator 110 breaks down agglomerates of drypowder before inhalation of the dry powder by a patient.

In general, the de-agglomerator 110 includes an inner wall 112 definingthe swirl chamber 114 extending along the axis A from the first end 118to the second end 120 of the chamber. The swirl chamber 114 includescircular cross-sectional areas arranged transverse to the axis A, whichdecrease from the first end 118 to the second end 120 of the swirlchamber 114. Preferably, the cross-sectional areas of the swirl chamber114 decrease monotonically such that any air flow traveling from thefirst end 118 of the swirl chamber 114 to the second end 120 will atleast in part collide with the inner wall 112 of the chamber. Inaddition, as shown best in FIGS. 1B and 9, the sidewall is preferablyconvex, i.e., arches inwardly towards the axis A.

Preferably, the dry powder supply port 122 of the de-agglomerator 110faces in a direction substantially parallel with the axis A of thechamber 114. Accordingly, as shown in FIG. 9, the air flow 1 enteringthe chamber 114 through the supply port 122 is at least initiallydirected parallel with respect to the axis A of the chamber.

Referring to FIGS. 1B, 3, 4, 5 and 9, the de-agglomerator 110additionally includes at least one inlet port 124 in the inner wall 112of the swirl chamber 114 adjacent to the first end 118 of the chamberproviding fluid communication between a region exterior to thede-agglomerator and the first end 118 of the swirl chamber 114.Preferably, the at least one inlet port comprises two diametricallyopposed inlet ports 124, 125 that extend in a direction substantiallytransverse to the axis A and substantially tangential to the circularcross-section of the swirl chamber 114. As a result, air flows,illustrated by arrows 2 and 3 in FIGS. 4 and 9, entering the chamber 114through the inlet ports 124, 125 are at least initially directedtransverse with respect to the axis A of the chamber and collide withthe air flow 1 entering through the supply port 122 to create a combinedturbulence air flow illustrated by arrow 4.

Referring to FIGS. 1B, 5 and 9, the de-agglomerator 110 includes vanes126 at the first end 118 of the swirl chamber 114 extending at least inpart radially outwardly from the axis A of the chamber. Each of thevanes 126 has an oblique surface 128 facing at least in part in adirection transverse to the axis A of the chamber. The vanes 126 aresized such that at least a portion of the combined air flows 4 collidewith the oblique surfaces 128. Preferably, the vanes comprise four vanes126, each extending between a hub 130 aligned with the axis A and thewall 112 of the swirl chamber 114.

Referring to FIG. 9, the geometry of the swirl chamber 114 causes thecombined air flows 4 and the entrained dry powder to follow a turbulentspiral path, or vortex, through the chamber. As will be appreciated, thedecreasing cross-sections of the swirl chamber 114 continuously changesthe direction and increases the velocity of the spiraling combined airflow 4 and entrained dry powder. Thus, particles and any agglomerates ofthe dry powder constantly impact against the wall 112 of the swirlchamber 114 and collide with each other, resulting in a mutual grindingor shattering action between the particles and agglomerates. Inaddition, particles and agglomerates deflected off the oblique surfaces128 of the vanes 126 cause further impacts and collisions. The constantimpacts and collisions cause any agglomerates of dry powder to breakinto additional particles, and cause the particles to be substantiallymicronized.

Upon exiting the swirl chamber 114, the direction of the combined airflow 14 and the entrained dry powder is again changed to a transversedirection with respect to the axis A, through the outlet port 132. Thecombined air flow 4 and the entrained dry powder retain a swirlcomponent of the flow, such that the air flow 4 and the entrained drypowder spirally swirls through the outlet port 132. Since the micronizedpowder and any remaining agglomerates maintain the swirl imparted fromswirl chamber 114, the swirling flow causes additional impacts in theoutlet port 132 so as to result in further breaking up of any remainingagglomerates prior to being inhaled by a patient. The de-agglomerator110, therefore, ensures that particles of the dry powder are smallenough for adequate penetration of the powder into a bronchial region ofa patient's lungs during inhalation.

As shown best in FIGS. 1B, 3, 4, 5 and 9, the de-agglomerator 110 ispreferably assembly from two pieces: a cup-like base 140 and a cover142. The base 140 and the cover 142 are connected to form the swirlchamber 114. The cup-like base 140 includes the wall 112 and the secondend 120 of the chamber and defines the outlet port 132. The base 140also includes the inlet ports of the swirl chamber 114. The cover 142forms the vanes 126 and defines the supply port 122.

As shown best in FIGS. 1B, 2, 3, 5 and 9, the cover 142 includes anupwardly extending cylindrical guide 144, and a chimney 146 extendingupwardly from the supply port 122 within the guide. The innercircumference 24 of the annular magazine 18 is received coaxially on theguide 144, such that the magazine can be rotated about the guide. Thebottom surface 30 of the magazine 18 includes an annular recess 72receiving a rim 148 of the base 140. The second hood 44 of the cap 14 isreceived over the chimney 146 of the supply port 122 to connect thedelivery passageway 16 of the cap 14 with the supply port 122 of thede-agglomerator 110. In addition, the inhaler 12 includes a coupler forsecuring the pre-metered dose assembly 10 to the de-agglomerator 110,such that the magazine 18 is free to be rotated with respect to thede-agglomerator. As shown best in FIGS. 1B, 5 and 9, the couplercomprises resilient tangs 74 of the magazine 18 engaging a bottomsurface of the rim 148 of the base 140, preventing the assembly 10 frombeing lifted off the de-agglomerator 110 yet allowing the magazine 18 torotate.

The base 140, the cover 142, the magazine 18 and the cap 14 arepreferably manufactured from a plastic such as polypropylene, acetal ormoulded polystyrene, but may be manufactured from metal or anothersuitable material. Preferably, the cover 142 includes an anti-staticadditive, such that the dry powder will not cling to the vanes 126. Thebase 140 and the cover 142 are connected in a manner that provides anair tight seal between the parts. For this purpose heat or cold sealing,laser welding or ultrasonic welding could be used, for example.

Referring now to FIG. 10, an inhaler 12 according to the presentdisclosure can be provided with a processor 80 for recording how manydoses are inhaled from the inhaler by a patient, and at what time thedoses are inhaled. The inhaler 12 includes indicators 82 attached to themagazine 18 corresponding to the dry powder reservoirs 20, and adetector 84 mounted on the de-agglomerator 110. The detector 84 providesa signal when one of the indicators 82 passes the detector as themagazine 18 is rotated with respect to the de-agglomerator 110. A signalfrom the detector 84, therefore, is indicative of a single dose of drypowder being inhaled by a patient through the inhaler 12. The indicatorscan comprise, for example, reflective strips, while the detector cancomprise an LED for directing light on passing reflective strip and areceiver for receiving the reflected light.

Although not shown, a counter provides a sum of the number of signalsprovided by the detector, while a clock provides a chronological timefor each signal provided by the detector. The processor 80 then providespredetermined calculations based upon the sum provided by the counterand the chronological times provided by the clock. The calculationsmight comprise, for example, the number of doses inhaled by a patientover a day, week or month. A memory stores the calculations provided bythe processor 80, and the inhaler 12 further includes a transmitter 86for transmitting the stored calculations to a remote device forutilizing the calculations. The transmitter might comprise a cable 86for connection to a doctor's computer upon a patient's visit to thedoctor's office, for example. The inhaler 12 includes a battery 88 forpowering the detector 84 and the processor 80.

It should be understood that the foregoing detailed description andpreferred embodiment is only illustrative of a breath-actuated drypowder inhaler 12 according to the present disclosure. Variousalternatives and modifications to the presently disclosed inhaler 12 canbe devised by those skilled in the art without departing from the spiritand scope of the present disclosure. For example, the pre-metered doseassembly 10 can be modified for with any inhaler and, in particular, anybreath-actuated dry powder inhaler. Accordingly, the present disclosureis intended to embrace all such alternatives and modifications that fallwithin the spirit and scope of the appended claims.

What is claimed is:
 1. A pre-metered dose assembly for use with abreath-actuated dry powder inhaler, comprising: a cap defining a drypowder delivery passageway for providing air to a dry powder supply portof a chamber of a breath-actuated dry powder inhaler; and a rigidunitary structure magazine including a plurality of integral reservoirsfor holding pre-metered doses of dry powder, one of the magazine and thecap movable with respect to the other of the magazine and the cap forsequentially positioning the reservoirs to be adjacent to the deliverypassageway of the cap; whereby a breath-induced low pressure in thechamber of the inhaler causes an air flow through the dry powderdelivery passageway and into the dry powder supply port, and the airflow entrains dry powder from the dry powder reservoir positioned in thepassageway into the chamber for inhalation by a patient using theinhaler; and a unitary structure means sealing each of the reservoirs ofthe magazine in a substantially airtight manner prior to the reservoirbeing positioned within the delivery passageway of the cap, andmaintaining said reservoirs unsealed otherwise.
 2. An assembly accordingto claim 1, wherein the magazine is movable with respect to the cap forsequentially positioning the plurality of the dry powder reservoirswithin the delivery passageway of the cap.
 3. An assembly according toclaim 2, wherein the magazine is annular such that rotation of theannular magazine sequentially positions the plurality of the dry powderreservoirs within the delivery passageway of the cap.
 4. An assemblyaccording to claim 1, further including means for indicating the numberof dry powder reservoirs containing dry powder.
 5. An assembly accordingto claim 4, wherein the cap covers the plurality of the dry powderreservoirs of the magazine and the means for indicating comprises atransparent portion of the cap.
 6. An assembly according to claim 1,wherein one of the magazine and the cap is movable with respect to theother of the magazine and the cap through a plurality of discreteincrements, wherein at each increment one of the plurality of the drypowder reservoirs is positioned within the delivery passageway of thecap.
 7. An assembly according to claim 1, wherein one of the magazineand the cap is movable with respect to the other of the magazine and thecap in only a single direction.
 8. An assembly according to claim 1,adapted such that the magazine and the cap will be unmovable withrespect to each other after all of the dry powder reservoirs of themagazine have been positioned in the dry powder delivery passageway ofthe cover.
 9. An assembly according to claim 1, wherein: one of themagazine and the cap includes a plurality of teeth; and the other of themagazine and the cap includes a resilient pawl sequentially passing overthe teeth during movement of one of the magazine and the cap withrespect to the other of the magazine and the cap, wherein the magazineis in one of the plurality of discrete increments when the pawl isbetween teeth.
 10. An assembly according to claim 9, wherein each of theplurality of teeth has a sloped first side allowing passage of the pawlin a first direction, and a straight second side preventing passage ofthe pawl in a second direction.
 11. An assembly according to claim 9,wherein the plurality of teeth includes one tooth having straight firstand second sides preventing passage of the pawl past said one tooth. 12.An assembly according to claim 1, further comprising dry powdercontained in the reservoirs of the magazine.
 13. An assembly accordingto claim 12, wherein each reservoir of the magazine contains a singledose of the dry powder.
 14. An assembly according to claim 13, whereinthe dry powder comprises a medicament composition having at least oneactive agent medicament adhered to a particulate carrier.
 15. Anassembly according to claim 1, wherein the unitary structure means forsealing comprises a film secured to the magazine and covering thereservoirs in a substantially airtight manner.
 16. A pre-metered doseassembly, comprising: a cap defining a delivery passageway; a rigidunitary structure magazine including a plurality of integral reservoirs,one of the magazine and the cap movable with respect to the other of themagazine and the cap for sequentially positioning the reservoirs to beadjacent to the delivery passageway of the cap; doses of dry powdercontained in the reservoirs of the magazine; a film secured to themagazine and covering the dry powder in the reservoirs in asubstantially airtight manner; and the cap includes means for piercingthe film above each of the reservoirs prior to the reservoir beingpositioned within the delivery passageway of the cap.
 17. An assemblyaccording to claim 16, wherein the dry powder delivery passageway of thecap includes a venturi.
 18. An assembly according to claim 1, whereinthe dry powder delivery passageway of the cap includes a venturi.
 19. Anassembly according to claim 1, wherein: the magazine is annular suchthat rotation of one of the magazine and the cap with respect to theother of the magazine and the cap sequentially positions the pluralityof the dry powder reservoirs within the delivery passageway of the cap,the magazine having a top surface defining the reservoirs; and the capincludes a lower surface received over the top surface of the magazine,the lower surface defining the dry powder delivery passageway extendingradially inwardly from an outer portion to an inner portion of the cap.20. An assembly according to claim 1, further comprising means forsecuring the cap to the magazine.
 21. An assembly according to claim 1,further comprising means for securing the assembly to a chamber of aninhaler.
 22. A breath-actuated dry powder inhaler including an assemblyaccording to claim 1, and further comprising: a chamber extending alongan axis between a first end and a second end; a dry powder supply portin the first end of the chamber in fluid communication with the drypowder delivery port of the cap; and an outlet port at a second end ofthe chamber; whereby a breath-induced low pressure at the outlet portcauses air flow into the chamber through the dry powder supply port,with the air flow through the dry powder supply port entraining drypowder into the chamber from the reservoir of the magazine positioned inthe delivery passageway.
 23. An inhaler according to claim 22, furthercomprising a de-agglomerator having: an inner wall defining the chamberextending along an axis from a first end to a second end; at least oneinlet port in the inner wall adjacent to the first end of the chamberproviding fluid communication between a region exterior to thede-agglomerator and the first end of the chamber; whereby abreath-induced low pressure at the outlet port also causes an air flowinto the chamber through the inlet port.
 24. An inhaler according toclaim 23, wherein the de-agglomerator further comprises vanes at thefirst end of the chamber extending at least in part radially outwardlyfrom the axis of the chamber, each of the vanes having an obliquesurface facing at least in part in a direction transverse to the axis.25. An inhaler according to claim 24, wherein the chamber of thede-agglomerator includes cross-sectional areas arranged transverse tothe axis, the cross-sectional areas decreasing monotonically from thefirst end to the second end of the chamber.
 26. An inhaler comprising: acap defining a dry powder delivery passageway; a magazine including aplurality of reservoirs for holding pre-metered doses of dry powder, oneof the magazine and the cap movable with respect to the other of themagazine and the cap for sequentially positioning the reservoirs withinthe delivery passageway of the cap; a chamber having an inner wallextending along an axis between a first end attached to the cap and themagazine and a second end, and cross-sectional areas arranged transverseto the axis and decreasing monotonically from the first end to thesecond end of the chamber; a dry powder supply port in the first end ofthe chamber in fluid communication with the dry powder delivery port ofthe cap, wherein the dry powder supply port faces in a directionsubstantially parallel to the axis; an outlet port at a second end ofthe chamber, wherein the outlet port extends substantially transverse tothe axis; vanes at the first end of the chamber extending at least inpart radially outwardly from the axis of the chamber, each of the vaneshaving an oblique surface facing at least in part in a directiontransverse to the axis; and at least one inlet port in the inner walladjacent to the first end of the chamber providing fluid communicationbetween a region exterior to the inhaler and the first end of thechamber, wherein the at least one inlet port extends in a directionsubstantially transverse to the axis and substantially tangential to thechamber.
 27. An inhaler according to claim 26, wherein the at least oneinlet port of the de-agglomerator comprises two diametrically opposedinlet ports.
 28. An inhaler according to claim 27, wherein: thede-agglomerator comprises a cup-like base closed with a cover to formthe chamber, the base defining the inner wall, and the second end of thechamber and the outlet port, the cover defining the first end of thechamber, the vanes and the supply port, and the base and the cover incombination defining the at least one inlet port, the cover including acylindrical guide extending upwardly from the chamber and a chimneyextending upwardly within the cylindrical guide from the supply port;the magazine is annular and has an inner circumferential surfacereceived coaxially on the cylindrical guide of the de-agglomerator forrotation of the magazine with respect to the de-agglomerator, themagazine having a top surface defining the dry powder reservoirs; andthe cap includes a lower surface received over the top surface of themagazine, the lower surface defining the dry powder delivery passagewayextending radially inwardly from from an outer portion to an innerportion of the cap, the cap further including a hood extendingdownwardly from the inner portion and received over the chimney of thede-agglomerator, the hood connecting the delivery passageway to thechimney and preventing rotation of the cap with respect to thede-agglomerator.
 29. An inhaler according to claim 28, furthercomprising: indicators attached to the magazine corresponding to the drypowder reservoirs; and a detector mounted on the de-agglomeratorproviding a dose signal upon an indicator passing the detector as themagazine is moved with respect to the de-agglomerator to position one ofthe reservoirs in the dry powder delivery passageway, whereby a dosesignal from the detector is indicative of the dispensing of a singlereservoir of dry powder through the inhaler.
 30. An inhaler according toclaim 29, further comprising: a counter providing a sum of the number ofdose signals provided by the detector; a clock for providing a time foreach dose signal provided by the detector; a processor for providingpredetermined calculations based upon the sum provided by the counterand the times provided by the clock; memory for storing the calculationsprovided by the processor; and means for transmitting the storedcalculations to a remote device for utilizing the calculations.
 31. Amethod of providing pre-metered doses of dry powder for patientinhalation through a breath-actuated dry powder inhaler including achamber extending along an axis from a first end to a second end, a drypowder supply port in the first end of the chamber, and an outlet portat the second end of the chamber, the method comprising: pre-metering aplurality of doses of dry powder; defining a dry powder deliverypassageway for providing air to the dry powder supply port of thechamber; positioning at least one of the pre-metered doses of dry powderwithin the delivery passageway; inducing a low pressure at the outletport of the chamber of the inhaler through patient inhalation to createan air flow through the dry powder delivery passageway, the dry powdersupply port, the chamber, and the outlet port and into the patient'slungs; and restricting the air flow through the delivery passageway sothat the air flow entrains the pre-metered dose of dry powder; directingthe breath-actuated air flow entraining the pre-metered dose of drypowder through the supply port in a substantially longitudinal directioninto the first end of the chamber with respect to the axis of thechamber; directing a second breath-actuated air flow in a substantiallytransverse direction into the first end of the chamber with respect tothe axis of the chamber such that the second air flow collides andsubstantially combines with the entraining air flow; deflecting aportion of the combined air flows in a substantially axial directiontowards the second end of the chamber; directing the remaining portionof the combined air flows in a substantially spiral path towards thesecond end of the chamber; and directing all the combined air flows fromthe second end of the chamber through the outlet port in a substantiallytransverse direction with respect to the axis of the chamber.
 32. Amethod according to claim 31, further comprising: sealing thepre-metered doses in an airtight manner; and unsealing the at least onepre-metered dose in the dry powder delivery passageway prior to inducinga low pressure at the outlet port of the inhaler.
 33. A method accordingto claim 31, further comprising: indicating the number of pre-metereddoses entrained through the delivery passageway.
 34. A method accordingto claim 31, further comprising: indicating a sum of the doses entrainedthrough the delivery passageway; indicating chronological times of whenthe doses were entrained through the delivery passageway; providingpredetermined calculations based upon the indicated sum and times; andstoring the calculations.
 35. A method according to claim 31, whereinthe second breath-actuated air flow is also directed tangentially intothe first end of the chamber.
 36. A method according to claim 35,wherein a third breath-actuated air flow is directed in a substantiallytransverse direction into the first end of the chamber with respect tothe axis of the chamber such that the third air flow collides andsubstantially combines with the entraining air flow and the second airflow.
 37. A method according to claim 35, wherein the combined air flowsare constricted between the first end and the second end of the chamber.38. A method of providing pre-metered doses of dry powder for patientinhalation through a breath-actuated dry powder inhaler including achamber extending along an axis from a first end to a second end, a drypowder supply port in the first end of the chamber, and an outlet portat the second end of the chamber, the method comprising: defining a drypowder delivery passageway for providing air to the dry powder supplyport of the chamber of the breath-actuated dry powder inhaler; andproviding a rigid unitary structure magazine including a plurality ofintegral reservoirs; pre-metering at least one dose of dry powder withineach reservoir of the magazine; moving the magazine with respect to thedry powder delivery passageway to sequentially position one of thereservoirs within the delivery passageway; inducing a low pressure atthe outlet port of the chamber of the inhaler through patient inhalationto create an air flow through the dry powder delivery passageway, thedry powder supply port, the chamber, and the outlet port and into thepatient's lungs; and restricting the air flow through the deliverypassageway so that the air flow entrains the at least one pre-metereddose of dry powder from the reservoir positioned in the passageway; andsealing the pre-metered doses in an airtight maimer within thereservoirs of the magazine using a film.
 39. A method according to claim38, wherein the film is provided as a plastic film.
 40. A methodaccording to claim 39, further comprising: unsealing a portion of thefilm above the reservoir positioned in the dry outlet powder deliverypassageway prior to inducing a low pressure at the outlet port of theinhaler.
 41. A breath-actuated dry powder inhaler comprising: apre-metered dose assembly including a cap defining a deliverypassageway, and a magazine including a plurality of reservoirs, andwherein one of the magazine and the cap is movable with respect to theother of the magazine and the cap for sequentially positioning thereservoirs within the delivery passageway of the cap; and ade-agglomerator including, an inner wall defining a chamber extendingalong an axis from a first end to a second end having an outlet port,wherein the chamber of the de-agglomerator includes cross-sectionalareas arranged transverse to the axis and decreasing monotonically fromthe first end to the second end of the chamber, a dry powder supply portin the first end of the chamber facing in a direction substantiallyparallel to the axis, and in fluid communication with the dry powderdelivery port of the cap, an outlet port at a second end of the chamberextending substantially transverse to the axis, at least one inlet portin the inner wall adjacent to the first end of the chamber and extendingsubstantially transverse to the axis and substantially tangential to thechamber, and vanes at the first end of the chamber extending at least inpart radially outwardly from the axis of the chamber, each of the vaneshaving an oblique surface facing at least in part in a directiontransverse to the axis.
 42. An inhaler according to claim 41, whereinthe at least one inlet port of the de-agglomerator comprises twodiametrically opposed inlet ports.
 43. An inhaler according to claim 42,wherein: the de-agglomerator comprises a cup-like base closed with acover to form the chamber, the base defining the inner wall, and thesecond end of the chamber and the outlet port, the cover defining thefirst end of the chamber, the vanes and the supply port, and the baseand the cover in combination defining the at least one inlet port, thecover including a cylindrical guide extending upwardly from the chamberand a chimney extending upwardly within the cylindrical guide from thesupply port; the magazine is annular and has an inner circumferentialsurface received coaxially on the cylindrical guide of thede-agglomerator for rotation of the magazine with respect to thede-agglomerator, the magazine having a top surface defining the drypowder reservoirs; and the cap includes a lower surface received overthe top surface of the magazine, the lower surface defining the drypowder delivery passageway extending radially inwardly from an outerportion to an inner portion of the cap, the cap further including a hoodextending downwardly from the inner portion and received over thechimney of the de-agglomerator, the hood connecting the deliverypassageway to the chimney and preventing rotation of the cap withrespect to the de-agglomerator.
 44. An assembly according to claim 41,wherein the magazine is movable with respect to the cap for sequentiallypositioning the plurality of the dry powder reservoirs within thedelivery passageway of the cap.
 45. An assembly according to claim 44,wherein the magazine is annular such that rotation of the annularmagazine sequentially positions the plurality of the dry powderreservoirs within the delivery passageway of the cap.
 46. An assemblyaccording to claim 41, wherein: one of the magazine and the cap includesa plurality of teeth; and the other of the magazine and the cap includesa resilient pawl sequentially passing over the teeth during movementbetween the magazine and the cap.
 47. An assembly according to claim 46,wherein each of the plurality of teeth has a sloped first side allowingpassage of the pawl in a first direction, and a straight second sidepreventing passage of the pawl in a second direction.
 48. An assemblyaccording to claim 46, wherein the plurality of teeth includes one toothhaving straight first and second sides preventing passage of the pawlpast said one tooth.
 49. An assembly according to claim 41, furthercomprising dry powder contained in the reservoirs of the magazine. 50.An assembly according to claim 49, wherein each reservoir of themagazine contains a single dose of the dry powder.
 51. An assemblyaccording to claim 16, wherein the film secured to the magazine andcovering the reservoirs in a substantially airtight manner comprises aplastic film.
 52. An assembly according to claim 16, wherein the filmsecured to the magazine and covering the dry powder in the reservoirs ina substantially airtight manner comprises a plastic film.
 53. Apre-metered dose assembly, comprising: a. cap defining a deliverypassageway; and a rigid unitary structure magazine including a pluralityof integral reservoirs, one of the magazine and the cap movable withrespect to the other of the magazine and the cap for sequentiallypositioning the reservoirs within the delivery passageway of the cap; aunitary structure means sealing each of the reservoirs of the magazinein a substantially airtight manner prior the reservoir being positionedwithin the delivery passageway of the cap, and maintaining saidreservoirs unsealed otherwise.
 54. An assembly according to claim 53,wherein the unitary structure means for sealing comprises a film securedto the magazine and covering the reservoirs in a substantially airtightmanner.
 55. An assembly according to claim 54, wherein the filmcomprises a plastic film.
 56. An assembly according to claim 54, whereinthe cap includes means for piercing the film above each of thereservoirs prior to the reservoir being positioned within the deliverypassageway of the cap.
 57. An assembly according to claim 53, whereinthe reservoirs are formed in a surface of the magazine and the unitarystructure means for sealing comprises a unitary surface of the capadapted to overlie each of the reservoirs prior to the reservoir beingpositioned within the delivery passageway of the cap, and continuous,resilient seals positioned on the surface of the magazine around each ofthe reservoirs, the resilient seals compressed between the overlyingsurface of the cap and the surface of the magazine.
 58. An assemblyaccording to claim 53, further comprising dry powder contained in thereservoirs of the magazine.
 59. An assembly according to claim 58,wherein each reservoir of the magazine contains a single dose of the drypowder.